The trials at each phase have a different purpose and

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Unformatted text preview: The trials at each phase have a different purpose and help scientists answer different questions: Phase I trials, researchers test a in a small group of people (10-80) for the first time to evaluate its safety. Phase II trials, the study is expanded to a larger group of people (30-200) to see if it is effective and to further evaluate its safety. 11/19/07 ME 128 26 Phases Phase III trials, the study is expanded to large groups of people (100 to 300) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow review and approval. Phase IV trials, post marketing studies provide additional information including the risks, benefits, and optimal use. 11/19/07 ME 128 27 Phase I Prior to Phase I significant efforts have previously been conducted: Bench studies Computer models and studies Animal studies Research studies However, design changes are anticipated during this phase. Asses...
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This note was uploaded on 07/08/2009 for the course ME 128 taught by Professor Laguette,s during the Fall '08 term at UCSB.

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